Ascendis Pharma Reports First Quarter 2025 Financial Results

In This Article:

Ascendis Pharma
Ascendis Pharma

- Q1 2025 revenue of €44.7 million for YORVIPATH® and €51.3 million for SKYTROFA®

- TransCon CNP NDA submitted in Q1 2025; MAA submission planned in Q3 2025

- Topline COACH combination trial (TransCon CNP + TransCon hGH) data expected in Q2 2025

- Conference call today at 4:30 pm ET

COPENHAGEN, Denmark, May 01, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the first quarter ended March 31, 2025, and provided a business update.

“The strong global launch of YORVIPATH positions 2025 to be an inflection point for Ascendis with growing revenue and a path to cashflow breakeven in the near term,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “We look forward to potential approvals of our third product, TransCon CNP, as a monotherapy in children with achondroplasia, and we believe the upcoming topline COACH combination trial data may demonstrate improved outcomes, including growth, compared to TransCon CNP alone. With our diversified pipeline, robust supply chain, and strong global commercial capabilities we are well-positioned to deliver on our commitment to provide patients with highly differentiated medicines.”

Select Highlights & Anticipated 2025 Milestones

  • TransCon PTH:
    (palopegteriparatide, marketed as YORVIPATH)

    • YORVIPATH revenue for the first quarter of 2025 totaled €44.7 million.

    • Continued strong start to U.S. YORVIPATH launch, with more than 1,750 prescriptions as of March 31, 2025, and more than 1,000 unique prescribing health care providers.

    • On track for commercial launch in at least five additional Europe Direct countries in 2025.

    • International Markets exclusive distribution agreements covering 75+ countries.

  • TransCon hGH:
    (lonapegsomatropin, marketed as SKYTROFA)

    • SKYTROFA revenue for the first quarter of 2025 totaled €51.3 million.

    • Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025, for Food & Drug Administration (FDA) review of supplemental Biologics License Application (BLA) for the treatment of adults with growth hormone deficiency.

    • During the third quarter of 2025, plan to submit an Investigational New Drug (IND) application or similar for a basket trial evaluating TransCon hGH in additional indications.

  • TransCon CNP
    (navepegritide)

    • Submitted New Drug Application (NDA) to the FDA for the treatment of children with achondroplasia in the first quarter of 2025; expect to submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) during the third quarter of 2025.

    • During the fourth quarter of 2025, plan to submit an IND or similar to investigate TransCon CNP alone or in combination with TransCon hGH for the treatment of hypochondroplasia.

  • TransCon CNP + TransCon hGH Combination Therapy
    (navepegritide plus lonapegsomatropin, marketed as SKYTROFA)

    • Topline Week 26 data from COACH, the combination TransCon CNP and TransCon hGH trial of children with achondroplasia (ages 2-11 years) expected in the second quarter of 2025.